MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO CHECKPOINT VERIFICATION PINS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	PFSD01009
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/13/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, when checking the x-rays the following day after a navio ukr procedure, it was noted that two verification check pins had been left in the patient.This report is for the second pin.Both pins were removed three days post-operation.
Additional Manufacturer Narrative
H3, h6: the device (psfd01009), used in treatment, was not returned for investigation.Dhr review found that no conditions that could contribute to the reported event were found.The reported product met manufacturing specifications prior to being released for distribution.A complaint history review found similar reports, this issue will continue to be monitored.This failure mode is identified in the risk profile.The navio surgical technique guide for knee arthroplasty (500197) includes in the "cementing and closing" section: "prior to closing the patient¿s incision, be sure to remove both the femoral and tibial bone checkpoint pins." and "when removing checkpoints pull in a perpendicular manner away from the bone.Do not pry or bend the checkpoint when removing." there is also a warning message in the system to alert the user to remove the checkpoint pins at the end of the case.We were not able to confirm if there was a relationship established between the reported event and the device.The reported issue was due to the checkpoint pin not being removed prior to closing the patient's incision per the ifu.Based on the investigation, no corrections or corrective actions required at this time.Per complaint details, it was noted on x-ray post-op uni-knee day-one, that the verification check pins had been left in the patient.Reportedly, according to the anz product complaint form, an additional surgical procedure was performed at 3-days post-op to remove the pins.It was communicated that the requested clinical documentation would not be provided; therefore, the patient impact beyond the retained pins and subsequent removal could not be determined.No further medical assessment could be rendered at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.

• Brand Name: NAVIO CHECKPOINT VERIFICATION PINS
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10935895
• Report Number: 3010266064-2020-02085
• Device Sequence Number: 10990497
• Product Code: OLO
• UDI-Device Identifier: 00885556628720
• UDI-Public: 00885556628720
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K191223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: PFSD01009
• Device Catalogue Number: PFSD01009
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/15/2020
• Supplement Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 08/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1